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From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299060/ https://www.ncbi.nlm.nih.gov/pubmed/34826340 http://dx.doi.org/10.1002/cpt.2476 |
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author | Thurin, Nicolas H. Pajouheshnia, Romin Roberto, Giuseppe Dodd, Caitlin Hyeraci, Giulia Bartolini, Claudia Paoletti, Olga Nordeng, Hedvig Wallach‐Kildemoes, Helle Ehrenstein, Vera Dudukina, Elena MacDonald, Thomas De Paoli, Giorgia Loane, Maria Damase‐Michel, Christine Beau, Anna‐Belle Droz‐Perroteau, Cécile Lassalle, Régis Bergman, Jorieke Swart, Karin Schink, Tania Cavero‐Carbonell, Clara Barrachina‐Bonet, Laia Gomez‐Lumbreras, Ainhoa Giner‐Soriano, Maria Aragón, María Neville, Amanda J. Puccini, Aurora Pierini, Anna Ientile, Valentina Trifirò, Gianluca Rissmann, Anke Leinonen, Maarit K. Martikainen, Visa Jordan, Sue Thayer, Daniel Scanlon, Ieuan Georgiou, Mary E. Cunnington, Marianne Swertz, Morris Sturkenboom, Miriam Gini, Rosa |
author_facet | Thurin, Nicolas H. Pajouheshnia, Romin Roberto, Giuseppe Dodd, Caitlin Hyeraci, Giulia Bartolini, Claudia Paoletti, Olga Nordeng, Hedvig Wallach‐Kildemoes, Helle Ehrenstein, Vera Dudukina, Elena MacDonald, Thomas De Paoli, Giorgia Loane, Maria Damase‐Michel, Christine Beau, Anna‐Belle Droz‐Perroteau, Cécile Lassalle, Régis Bergman, Jorieke Swart, Karin Schink, Tania Cavero‐Carbonell, Clara Barrachina‐Bonet, Laia Gomez‐Lumbreras, Ainhoa Giner‐Soriano, Maria Aragón, María Neville, Amanda J. Puccini, Aurora Pierini, Anna Ientile, Valentina Trifirò, Gianluca Rissmann, Anke Leinonen, Maarit K. Martikainen, Visa Jordan, Sue Thayer, Daniel Scanlon, Ieuan Georgiou, Mary E. Cunnington, Marianne Swertz, Morris Sturkenboom, Miriam Gini, Rosa |
author_sort | Thurin, Nicolas H. |
collection | PubMed |
description | In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother‐child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population. |
format | Online Article Text |
id | pubmed-9299060 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92990602022-07-22 From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding Thurin, Nicolas H. Pajouheshnia, Romin Roberto, Giuseppe Dodd, Caitlin Hyeraci, Giulia Bartolini, Claudia Paoletti, Olga Nordeng, Hedvig Wallach‐Kildemoes, Helle Ehrenstein, Vera Dudukina, Elena MacDonald, Thomas De Paoli, Giorgia Loane, Maria Damase‐Michel, Christine Beau, Anna‐Belle Droz‐Perroteau, Cécile Lassalle, Régis Bergman, Jorieke Swart, Karin Schink, Tania Cavero‐Carbonell, Clara Barrachina‐Bonet, Laia Gomez‐Lumbreras, Ainhoa Giner‐Soriano, Maria Aragón, María Neville, Amanda J. Puccini, Aurora Pierini, Anna Ientile, Valentina Trifirò, Gianluca Rissmann, Anke Leinonen, Maarit K. Martikainen, Visa Jordan, Sue Thayer, Daniel Scanlon, Ieuan Georgiou, Mary E. Cunnington, Marianne Swertz, Morris Sturkenboom, Miriam Gini, Rosa Clin Pharmacol Ther Research In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother‐child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population. John Wiley and Sons Inc. 2021-11-26 2022-01 /pmc/articles/PMC9299060/ /pubmed/34826340 http://dx.doi.org/10.1002/cpt.2476 Text en © 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Thurin, Nicolas H. Pajouheshnia, Romin Roberto, Giuseppe Dodd, Caitlin Hyeraci, Giulia Bartolini, Claudia Paoletti, Olga Nordeng, Hedvig Wallach‐Kildemoes, Helle Ehrenstein, Vera Dudukina, Elena MacDonald, Thomas De Paoli, Giorgia Loane, Maria Damase‐Michel, Christine Beau, Anna‐Belle Droz‐Perroteau, Cécile Lassalle, Régis Bergman, Jorieke Swart, Karin Schink, Tania Cavero‐Carbonell, Clara Barrachina‐Bonet, Laia Gomez‐Lumbreras, Ainhoa Giner‐Soriano, Maria Aragón, María Neville, Amanda J. Puccini, Aurora Pierini, Anna Ientile, Valentina Trifirò, Gianluca Rissmann, Anke Leinonen, Maarit K. Martikainen, Visa Jordan, Sue Thayer, Daniel Scanlon, Ieuan Georgiou, Mary E. Cunnington, Marianne Swertz, Morris Sturkenboom, Miriam Gini, Rosa From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title | From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title_full | From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title_fullStr | From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title_full_unstemmed | From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title_short | From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
title_sort | from inception to conception: genesis of a network to support better monitoring and communication of medication safety during pregnancy and breastfeeding |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299060/ https://www.ncbi.nlm.nih.gov/pubmed/34826340 http://dx.doi.org/10.1002/cpt.2476 |
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